Recall Action Notification - STA R Max. An in vitro diagnostic medical device (IVD)
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Recall Action Notification STA R Max. An in vitro diagnostic medical device (IVD) © Commonwealth of Australia 2021. This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to .
System for Australian Recall Actions
Important information on the System for Australian Recall Actions
The TGA publishes information about therapeutic goods supplied in the Australian market that have been
subject to a recall action in a publicly searchable database.
Recall action means action taken by the responsible entity (being the person who is responsible for taking the
recall action) to resolve a problem with therapeutic goods supplied in the Australian market that have, or may
potentially have, deficiencies relating to safety, quality, efficacy (performance) or presentation.
• Recall actions include: the permanent removal of therapeutic goods from supply in the market, the
taking of corrective action in relation to therapeutic goods (such as repair, modification, adjustment or
relabelling) and, in the case of medical devices that have been implanted into patients, the issuing of a
hazard alert containing information for health practitioners on how to manage patients.
• More information about Australian recall actions is available at
• If you are taking a medicine, using a medical device or have had a medical device implanted into you,
that is the subject to a recall action, and you have any concerns you should seek advice from a health
professional.
About the release of this information
While reasonable care is taken to ensure that the information is an accurate record of recall actions that responsible
entities have reported to the TGA or of which the TGA has become aware, the TGA does not guarantee or warrant the
accuracy, reliability, completeness or currency of the information or its usefulness in achieving any purpose.
To the fullest extent permitted by law, including but not limited to section 61A of the Therapeutic Goods Act 1989, the
TGA will not be liable for any loss, damage, cost or expense incurred in or arising by reason of any person relying on
this information.
The information contained in the SARA database is released under s 61(5C) of the Therapeutic Goods Act 1989.
Copyright restrictions apply to the System of Australian Recall actions (SARA) .
Report generated 30/06/2021 11:08:28 PM Page 2 of 4System for Australian Recall Actions
Recall detail
Type of Producti Medical Device
TGA Recall Referenceii RC-2021-RN-01433-1
Product STA R Max. An in vitro diagnostic medical device (IVD)
Name/Descriptioniii
Software version: 4.06
ARTG 184474
(Diagnostica Stago Pty Ltd - Instrument/analyser IVDs)
Recall Action Leveliv Hospital
Recall Action Class II
Classificationv
Recall Action
Commencement Datevi 23/06/2021
Responsible Entityvii Diagnostica Stago Pty Ltd
Reason / Issueviii Customer feedback has highlighted an unusual frequency of abnormally shortened APTT
(Activated partial thromboplastin time) clotting times on STA R Max instruments, since the
software version 4.06 update.
Stago investigation has identified an issue on “special” or “special plus” washes with STA-
Desorb U on reagent needles (#2 and #3) when a level detection error (LLD) occurs. This
washing anomaly is most commonly present in a specific context of non-recommended
use (unloading and reloading of bottles of reagents already used, with entry of an incorrect
residual volume by the user).
If a LLD error appears on a test with a special wash, cross-contamination may occur with
different test combinations.
Recall Actionix Product Defect Correction
Recall Action Stago is advising customers that a software update, version 4.07.01, is available and will
Instructionsx
be installed shortly by a Stago representative. In the interim, users are recommended to
not unload-reload reagents from the STA R Max before the end of the bottle. If this is
necessary, ensure the correct entry of the residual volume is made when reloading a vial
that has already been used and has not yet been completed.
Contact Informationxi 03 9840 5555 - Vicki Guppy
Footnotes
i Type of Product: Medicine, Medical Device, or Biological
ii TGA Recall Reference: Unique number given by the TGA
iii Product Name/Description: Brand name (including active ingredient for medicines) and may include generic reference
for the kind of medical devices. Includes all necessary information such as affected: catalogue / model and / or batch /
Report generated 30/06/2021 11:08:28 PM Page 3 of 4
The TGA publishes Australian recall actions in a searchable database to ensure the public has access to information
about therapeutic products that have been recalled from the Australian market. If you are concerned about your health
or if you have experienced an adverse event please seek advice from a health professional as soon as possible.
Please read all the important information at the beginning of this report.System for Australian Recall Actions
serial numbers.
iv Recall Action Level: The level to which the recall action is to be undertaken. This is based on the significance of the
risk and the channels through which the goods have been distributed. The recall action levels are / Wholesale /
Hospital / Retail / Consumer.
• Wholesale - includes wholesalers and state purchasing authorities.
• Hospital - includes nursing homes and institutions, hospital pharmacists, ambulance services, blood and tissue
banks and laboratories as well as wholesale as appropriate.
• Retail - includes retail pharmacists, medical, dental and other health care professionals as well as wholesale
and hospital as appropriate.
• Consumer - includes patients and consumers, as well as wholesale, hospital and retail levels as appropriate.
v Recall Action Classification**: Recall actions of therapeutic goods are classified based on the potential risk the
deficiency poses to patients / consumers. They are classified as Class I, Class II or Class III.
• Class I - A situation in which there is a reasonable probability that the use of, or exposure to, the deficient
therapeutic good(s) will cause serious adverse health consequences or death.
• Class II - A situation in which use of, or exposure to, the deficient therapeutic good(s) may cause temporary or
medically reversible adverse health consequences, or where the probability of serious adverse health
consequences is remote.
• Class III- A situation in which use of, or exposure to, the deficient therapeutic good(s) is not likely to cause
adverse health consequences.
vi Recall Action Commencement Date: The date the recall strategy and communication was agreed by the TGA.
vii Responsible Entity: Sponsor / Supplier / Importer responsible for the recall actions.
viii Reason / Issue: Reason for the recall action.
ix Recall Action**: Recall action is an action taken to resolve a problem with a therapeutic good already supplied in the
market for which there are issues or deficiencies in relation to safety, quality, efficacy (performance) or presentation.
There are four distinct recall actions – recall, product defect correction, hazard alert and product defect alert.
• Recall - The permanent removal of an affected therapeutic good from supply or use in the market.
• Product defect correction - Repair, modification, adjustment or re-labelling of a therapeutic good. The
corrective action may take place at the user's premises or any other agreed location.
• Hazard alert - Information issued to healthcare professionals about issues or deficiencies relating to an
implanted medical device or biological product and advice about the ongoing management of patients.
• Product defect alert - Information issued to raise awareness about issues or deficiencies for a therapeutic
good where a recall action will result in interruption of patient treatment or a medicine shortage, including advice
to reduce potential risks of using affected goods.
x Recall Action Instructions: What customers with affected goods should do.
xi Contact Information: Who the customer should contact for additional information and clarification regarding the recall
action.
** These definitions are applicable to the 2017 URPTG (Implemented from Jan 15 2018). Recall Action types and
Recall Action Classifications prior to 15 Jan 2018 can be found at:
https://www.tga.gov.au/sites/default/files/recalls-urptg-170412.pdf
Report generated 30/06/2021 11:08:28 PM Page 4 of 4
The TGA publishes Australian recall actions in a searchable database to ensure the public has access to information
about therapeutic products that have been recalled from the Australian market. If you are concerned about your health
or if you have experienced an adverse event please seek advice from a health professional as soon as possible.
Please read all the important information at the beginning of this report.0045564-24/06/2021-DGDMF-MDS-A - Allegato Utente 1 (A01)
Alla C.A. del responsabile del laboratorio
Milano, 22 giugno 2021
Riferimento: RC-21-0021
COMUNICAZIONE DI SICUREZZA
Versione software 4.06 dell’analizzatore STA R Max®
Caro Cliente,
Secondo quanto riportato nel nostro database, ad oggi lei utilizza un analizzatore STA R Max®.
Qualora il suo strumento sia aggiornato alla versione software 4.06, la preghiamo di prendere
attentamente visione di questa informativa sulla sicurezza riguardante possibili anomalie sul
risciacquo dell’ago #2 e #3. Questa informativa non è rivolta ad utilizzatori di analizzatori STA R Max®
che utilizzano una versione software precedente alla 4.06.
Descrizione:
Abbiamo ricevuto alcune segnalazioni relative ad una insolita frequenza dei tempi di coagulazione del
test APTT anormalmente ridotti, ottenuti su analizzatori STA R Max® aggiornati alla versione software
4.06.
In seguito ad una verifica interna è stato riscontrato un problema sul lavaggio “special” o “special +”
con STA-Desorb U a carico degli aghi reagenti (#2 e #3), legato ad un errore di rilevamento del livello
(LLD). Questa anomalia di lavaggio si riscontra comunemente nel caso di un utilizzo non
raccomandato (scarico e successivo caricamento a bordo, con inserimento da parte dell’utilizzatore di
un volume residuo errato, dei flaconi di reagenti già utilizzati).
Nel caso in cui si verifichi un errore LLD su un test che prevede un lavaggio speciale si può verificare
una contaminazione incrociata con altri test.
Sulla base dell’analisi dei rischi da noi condotta il caso più critico riguarda la contaminazione del test
APTT da parte del reagente del Fibrinogeno, con una conseguente riduzione significativa del tempo di
coagulazione dell’APTT. Inoltre, essendo l’APTT e il Fibrinogeno test di routine, aumenta la probabilità
che ciò si verifichi.
È possibile rilevare la riduzione del risultato del test APTT sul plasma di un paziente normale, il tempo
ottenuto sarà infatti anormalmente breve (più breve del tempo di riferimento del laboratorio). Al
contrario, potrebbe essere difficile rilevare la riduzione di un APTT sul plasma di un paziente
patologico.
Azioni:
Una nuova versione software è già disponibile: la versione 4.07.01 verrà installata a breve dal
rappresentate Stago.
In attesa che il suo analizzatore venga aggiornato, al fine di limitare il rischio di un errore LLD dei
reattivi, le raccomandiamo di non scaricare e successivamente ricaricare a bordo dell’analizzatore
STA R Max® reattivi non ancora esauriti.
1/2Nel caso ciò si renda necessario, le raccomandiamo di assicurarsi di inserire il valore di volume
residuo al momento di caricare nuovamente a bordo un flacone che è già stato utilizzato ma che non è
ancora esaurito.
Questa procedura consentirà una gestione ottimale dei volumi da parte dell’analizzatore e quindi di
evitare il rischio che l’anomalia descritta si verifichi.
Sulla base dell’analisi dei rischi da noi condotta, considerato che i risultati dei pazienti sono interpretati
in un contesto clinico-biologico globale, se non avete scaricato-ricaricato i reagenti a bordo del vostro
STA R Max® senza inserire l’esatto volume residuo, è improbabile che questo difetto si sia verificato o
che possa avere conseguenze dannose per la salute del paziente. Di conseguenza, non è necessario
rivedere i risultati dei pazienti precedenti.
La preghiamo di restituire, via fax o via e-mail, al suo rappresentante Stago il modulo allegato
correttamente compilato a conferma di aver letto questa informativa e dell’impegno ad
applicare le istruzioni in essa contenute.
L’autorità amministrativa competente del paese d’origine (Francia), così come quella locale di
competenza sono state informate in merito a tale Comunicazione di Sicurezza.
Per ulteriori informazioni, si prega di contattare il proprio rappresentante Stago.
La preghiamo di accettare le nostre scuse per questo inconveniente. La ringraziamo in anticipo per il
vostro supporto.
Distinti saluti,
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